human-andanimal-derivedaminoacidsshouldbeavoided.Ifuseofaminoacidsofanimalorigincannotbeavoided,therespectivematerialshouldmeettherequirementsoftheEuropeanPharmacopoeiageneralchapter5.2.8.MinimisingtheRiskofTransmittingAnimalSpongiformEncephalopathyAgentsViaHumanandVeterinaryMedicinalProducts.TherequirementforBSE/TSE-free...
<905>UNIFORMITY OF DOSAGE UNITS(Harmonized Chapter, Official April 1,2006)……2780制剂单位的含量均匀度(协调的章节2006.4.1) <911>VISCOSITY……2785粘度 <921>WATER DETERMINATION……2785水测定法 <941>X-RAY DIFFRACTION……2788X光衍射 General Information通用信息 <1010>ANALYTICAL DATA—INTERPRETATION AND ...
2778 制剂单位的含量均匀度<905>UNIFORMITY OF DOSAGE UNITS (Harmonized Chapter, Official April 1,2006)……2780 制剂单位的含量均匀度(协调的章节2006.4.1)<911>VISCOSITY……2785 粘度<921>WATER DETERMINATION……2785 水测定法<941>X-RAY DIFFRACTION……2788 X光衍射 General Information 通用信息<1010>...
General Noti-ces, the individual monographs, and the General Tests and Assays chapters of this Pharmacopeia.á1004ñ MUCOSAL DRUG PRODUCTS—PERFORMANCE TESTSINTRODUCTIONMucosal drug products deliver drug substances to the body via the mucosal route. For the purposes of this chapter, themucosal route...
<905>UNIFORMITY OF DOSAGE UNITS(Harmonized Chapter, Official April 1,2006)……2780制剂单位的含量均匀度(协调的章节2006.4.1) <911>VISCOSITY……2785粘度 <921>WATER DETERMINATION……2785水测定法 <941>X-RAY DIFFRACTION……2788X光衍射 General Information通用信息 <1010>ANALYTICAL DATA—INTERPRETATION AND ...
＜171＞VITAMIN B12 ACTIVITY ASSAY……2548 维生素B12活性测定法 Chemical Tests and assays 化学实验与测定法 ＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES (2549)鉴别－有机氮碱？＜191＞IDENTIFICATION TESTS—GENERAL……2550 鉴别实验－通用 ＜193＞IDENTIFICATION—TETRACYCLINES……2551 鉴别－四环素 ...
＜171＞VITAMIN B12 ACTIVITY ASSAY……2548 维生素B12活性测定法 Chemical Tests and assays 化学实验与测定法 ＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES (2549)鉴别－有机氮碱？＜191＞IDENTIFICATION TESTS—GENERAL……2550 鉴别实验－通用 ＜193＞IDENTIFICATION—TETRACYCLINES……2551 鉴别－四环素 ...
1、DISSOLUTION溶出度(USP39-NF34Page540)GeneralchapterDissolutionv711isbeingharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopoeiaand/ortheJapanesePharmacopoeia.Thesepharmacopeiashaveundertakentonotmakeanyunilateralchangetothisharmonizedchapter.通则溶出度与欧盟药典和日本药典中的相应部分相统一。这三部药典承诺不做...
General chapter Dissolution <711> is bete Acceptance Table. It is not necessary to continue testing through the last stage (up to 24 units) when criteria are not met during the first stage testing, and evidence of cross-linking is observed. ...
1、USP29-通用章节指导目录(附录)第2页 共7页8通用章节指导Guide to General Chapters目录中此颜色并且带有“ * ”的为新增内容General Requirements for Test and Assays 检查与含量分析的一般要求V 1 INJECTIONS 2455 注射剂V 11 USP REFERENCE STANDARDS 2458 USP 对照品Apparatus for Test and Assays 用于检查...